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Knee OsteoarthritisNCT07677215

ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty

A study testing Ropivacaine 0.2% Injectable Solution, Dexamethasone and Dexmedetomidine in people with Knee Osteoarthritis, run by Poznan University of Medical Sciences at 2 sites in Poland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective randomized controlled trial aims to compare the analgesic efficacy and safety of three adjuvant strategies for ultrasound-guided Adductor Canal Block (ACB) and iPACK block in patients undergoing elective total knee arthroplasty under spinal anesthesia. Read more about this study

Who is it for?
Ages 60 to 100 years
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Ropivacaine 0.2% Injectable Solution, Dexamethasone and Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
2 sitesPoland
Study dates
20 May 2026to 1 Oct 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 60 and 100 years
  • Scheduled for elective primary unilateral total knee arthroplasty
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Ability to understand study procedures and provide written informed consent
  • Eligibility for spinal anesthesia and ultrasound-guided regional anesthesia according to institutional standards

Who cannot join

  • Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine, or any study-related medication
  • Contraindications to spinal anesthesia or peripheral nerve blocks
  • Coagulation disorders or anticoagulant therapy preventing safe regional anesthesia
  • Infection at the planned puncture site or systemic infection
  • Severe neurological disorders affecting lower limb sensory or motor function
  • Severe hepatic, renal, or uncontrolled cardiovascular disease
Show all 10Show fewer
  • Clinically significant bradycardia or advanced atrioventricular conduction abnormalities
  • Chronic opioid use for more than 3 months before surgery
  • Uncontrolled diabetes mellitus or contraindications to dexamethasone administration
  • Inability or refusal to provide written informed consent

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Malgorzata Reysner, MD PhD contact

+48 61 8310122

mreysner@ump.edu.pl

Tomasz Reysner, MD PhD contact

+48 61 8310122

treysner@ump.edu.pl

Poland2 sites, 2 recruiting
  • The John Paul II Catholic University of Lublin

    Lublin

    Michał Borys, MD PhD

    Recruiting
  • Poznan University of Medical Sciences

    Poznan, 62-701

    Malgorzata Reysner, M.D. Ph.D., +48 61 873 83 03, mreysner@ump.edu.pl

    Recruiting

Other trials in Poland

About this study

Official title: Comparison of the Efficacy and Safety of Three Adjuvant Strategies for ACB and iPACK Blocks in Patients Undergoing Elective Total Knee Arthroplasty: A Prospective, Randomized Clinical Trial

This prospective randomized controlled trial aims to compare the analgesic efficacy and safety of three adjuvant strategies for ultrasound-guided Adductor Canal Block (ACB) and iPACK block in patients undergoing elective total knee arthroplasty under spinal anesthesia. All participants will receive standardized spinal anesthesia with 0.5% ropivacaine combined with ACB and iPACK blocks using 0.2% ropivacaine. Patients will be randomized into one of three groups: standard ACB + iPACK without adjuvants, ACB + iPACK with intravenous dexamethasone 8 mg, or ACB + iPACK with intravenous dexamethasone 8 mg combined with perineural dexmedetomidine added to both regional blocks.

The primary outcome will be total postoperative opioid consumption during the first 48 hours after surgery expressed as intravenous morphine equivalents. Secondary outcomes will include pain intensity at rest and during movement, duration of analgesia, time to first rescue analgesia, quadriceps muscle strength, early mobilization, adverse events, inflammatory markers, and length of hospital stay.

Read the detailed description

Postoperative pain following total knee arthroplasty (TKA) remains a major clinical challenge and may negatively affect early mobilization, rehabilitation, patient satisfaction, and postoperative recovery. Inadequate pain control after TKA is associated with increased opioid consumption and opioid-related adverse events, including nausea, vomiting, sedation, urinary retention, respiratory depression, and postoperative delirium, particularly in elderly patients.

Ultrasound-guided Adductor Canal Block (ACB) combined with iPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) block has become an increasingly popular regional anesthesia strategy for TKA because it may provide effective analgesia while preserving quadriceps muscle strength and facilitating early mobilization. The ACB primarily targets the sensory innervation of the anterior and medial aspects of the knee, whereas the iPACK block supplements analgesia of the posterior knee capsule.

Several adjuvant medications have been investigated to prolong the duration and improve the quality of peripheral nerve blocks. Intravenous dexamethasone is widely used as a perioperative analgesic adjunct and may prolong postoperative analgesia while also reducing postoperative nausea and vomiting. Perineural dexmedetomidine has been shown to prolong sensory blockade, improve analgesia quality, and reduce opioid requirements. However, the optimal combination of systemic and perineural adjuvants for ACB and iPACK blocks in TKA remains unclear.

The aim of this prospective randomized controlled trial is to compare three perioperative analgesic strategies in patients undergoing elective primary unilateral total knee arthroplasty under spinal anesthesia:

Standard ACB + iPACK without adjuvants, ACB + iPACK with intravenous dexamethasone 8 mg, ACB + iPACK with intravenous dexamethasone 8 mg combined with perineural dexmedetomidine.

All participants will receive standardized spinal anesthesia with 0.5% ropivacaine (3-4 mL). Ultrasound-guided ACB and iPACK blocks will be performed using 20 mL of 0.2% ropivacaine for each block. In the dexmedetomidine group, 12.5 µg of dexmedetomidine will be added to each regional block.

The primary endpoint of the study will be total postoperative opioid consumption during the first 48 postoperative hours expressed as intravenous morphine equivalents. Secondary endpoints will include postoperative pain scores at rest and during movement, time to first rescue analgesia, duration of analgesia, quadriceps muscle strength, early mobilization, opioid-related adverse events, dexmedetomidine-related adverse events such as bradycardia and hypotension, inflammatory markers, and length of hospital stay.

The study hypothesis is that intravenous dexamethasone will improve postoperative analgesia compared with standard ACB + iPACK alone, while the addition of low-dose perineural dexmedetomidine will further prolong analgesia duration and reduce opioid consumption without significantly increasing adverse events or impairing postoperative mobilization.

Being tested
Ropivacaine 0.2% Injectable Solution, Dexamethasone, Dexmedetomidine
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropivacaine 0.2% Injectable SolutionDrug

    Also called Ropimol

    Ropivacaine 0.2% used for ultrasound-guided ACB and iPACK blocks (20 mL per block).

  • DexamethasoneDrug

    Also called Dexaven

    Intravenous dexamethasone 8 mg administered perioperatively.

  • DexmedetomidineDrug

    Also called Dexdor

    Perineural dexmedetomidine 12.5 μg added to each regional block (ACB and iPACK).

Study groups in NCT07677215
Study groupRoleWhat they receive
ACB + iPACK Without AdjuvantsActive comparatorParticipants will receive standardized spinal anesthesia with 0.5% ropivacaine (3-4 mL) combined with ultrasound-guided Adductor Canal Block (ACB) and iPACK block using 20 mL of 0.2% ropivacaine for each block. No adjuvant medications will be administered. Standardized multimodal postoperative analgesia will be provided according to institutional protocol.
Receives: Drug: Ropivacaine 0.2% Injectable Solution
ACB + iPACK With Intravenous DexamethasoneExperimentalParticipants will receive standardized spinal anesthesia with 0.5% ropivacaine (3-4 mL) combined with ultrasound-guided Adductor Canal Block (ACB) and iPACK block using 20 mL of 0.2% ropivacaine for each block. Intravenous dexamethasone 8 mg will be administered perioperatively. Standardized multimodal postoperative analgesia will be provided according to institutional protocol.
Receives: Drug: Dexamethasone
ACB + iPACK With Intravenous Dexamethasone and Perineural DexmedetomidineExperimentalParticipants will receive standardized spinal anesthesia with 0.5% ropivacaine (3-4 mL) combined with ultrasound-guided Adductor Canal Block (ACB) and iPACK block using 20 mL of 0.2% ropivacaine for each block. Perineural dexmedetomidine 12.5 µg will be added to each regional block. Intravenous dexamethasone 8 mg will be administered perioperatively. Standardized multimodal postoperative analgesia will be provided according to institutional protocol.
Receives: Drug: Dexmedetomidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total postoperative opioid consumption during the first 48 hours after surgery

    Total postoperative opioid consumption will be recorded during the first 48 hours after total knee arthroplasty and converted to intravenous morphine milligram equivalents.

    Measured: 48 hours after surgery

Secondary outcomes (15)
  1. Pain intensity at rest

    Pain intensity at rest will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.

    Measured: 6 hours after surgery

  2. Pain intensity at rest

    Pain intensity at rest will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.

    Measured: 12 hours after surgery

  3. Pain intensity at rest

    Pain intensity at rest will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.

    Measured: 24 hours after surgery

  4. Pain intensity at rest

    Pain intensity at rest will be assessed using the Numeric Rating Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.

    Measured: 48 hours after surgery

  5. Pain intensity during movement assessed using the Numeric Rating Scale

    Pain intensity during movement will be assessed using the Numeric Rating Scale during active or passive knee movement, where 0 indicates no pain and 10 indicates the worst imaginable pain.

    Measured: 6 hours postoperatively

  6. Pain intensity during movement assessed using the Numeric Rating Scale

    Pain intensity during movement will be assessed using the Numeric Rating Scale during active or passive knee movement, where 0 indicates no pain and 10 indicates the worst imaginable pain.

    Measured: 12 hours postoperatively

  7. Pain intensity during movement assessed using the Numeric Rating Scale

    Pain intensity during movement will be assessed using the Numeric Rating Scale during active or passive knee movement, where 0 indicates no pain and 10 indicates the worst imaginable pain.

    Measured: 24 hours postoperatively

  8. Pain intensity during movement assessed using the Numeric Rating Scale

    Pain intensity during movement will be assessed using the Numeric Rating Scale during active or passive knee movement, where 0 indicates no pain and 10 indicates the worst imaginable pain.

    Measured: 48 hours postoperatively

  9. Time to first rescue analgesia

    Time from the end of surgery to the first request for or administration of rescue analgesic medication.

    Measured: 48 hours after surgery

  10. Quadriceps muscle strength of the operated limb

    Quadriceps muscle strength of the operated limb will be assessed using a standardized motor strength scale.

    Measured: 6 hours postoperatively

  11. Quadriceps muscle strength of the operated limb

    Quadriceps muscle strength of the operated limb will be assessed using a standardized motor strength scale.

    Measured: 12 hours postoperatively

  12. Quadriceps muscle strength of the operated limb

    Quadriceps muscle strength of the operated limb will be assessed using a standardized motor strength scale.

    Measured: 24 hours postoperatively

  13. Quadriceps muscle strength of the operated limb

    Quadriceps muscle strength of the operated limb will be assessed using a standardized motor strength scale.

    Measured: 48 hours postoperatively

  14. Time to first postoperative mobilization

    Time from the end of surgery to the first successful mobilization with assistance, according to the institutional rehabilitation protocol.

    Measured: 48 hours postoperatively

  15. Length of hospital stay

    Length of hospital stay will be defined as the number of days from surgery to hospital discharge.

    Measured: up to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2026
  2. Study start20 May 2026
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07677215
Sponsor's protocol ID
6/2026
Status last verified
Nov 2026
First submitted
20 May 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the reported results will be made available to qualified researchers upon reasonable request after publication of the primary study results. Shared data may include demographic data, perioperative variables, postoperative pain scores, opioid consumption, adverse events, and other study-related outcomes. Data will be provided after removal of all direct identifiers in accordance with applicable data protection regulations.

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine 0.2% Injectable Solution, Dexamethasone and Dexmedetomidine in people with Knee Osteoarthritis, run by Poznan University of Medical Sciences at 2 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Malgorzata Reysner, MD PhD (+48 61 8310122, mreysner@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total postoperative opioid consumption during the first 48 hours after surgery (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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